Sterigenics U.S., LLC (contract sterilizer, Charlotte, NC): 15 new FDA device listings, incl. radioimmunoassay, thyroid-stimulating hormone
Sterigenics U.S., LLC (Charlotte, North Carolina): 15 new FDA device listings, incl. radioimmunoassay, thyroid-stimulating hormone. Its amount of 15 is top-decile (96th percentile of 2,570 records). Dated 153 days ago, it serves as a historical benchmark. Score 80/100. As of 2026-10-28, from openFDA device registration and listing endpoint (U.S. Food and Drug Administration).
Data as of · Compiled by Zalwin from openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
amount: 15 · 96th percentile of 2,570 DeviceEstablishmentPulse records · 15.0x the median
Free preview: all 15 published fields of this record are shown below. Locked: 32 related NC DeviceEstablishmentPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Establishment | Sterigenics U.S., LLC |
| Owner / operator | Sotera Health LLC |
| Role | Contract sterilizer |
| Establishment types | Sterilize Medical Device for Another Party (Contract Sterilizer) |
| Location | Charlotte, NC, US |
| New listings | 15 |
| Devices | Radioimmunoassay, Thyroid-Stimulating Hormone; Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment; Cutaneous Tissue Adhesive With Mesh; Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed; System, Cement Removal Extraction; Arthroscope; Burr, Orthopedic; Mesh, Surgical, Polymeric; Screw, Fixation, Bone |
| Product codes | JLW, HWE, OMD, OTO, LZV, HRX, HTT, FTL, HWC |
| Device classes | Class I, Class II |
| Medical specialties | Clinical Chemistry, General, Plastic Surgery, Orthopedic |
| Brand names | MICRO OSCBLD COARS 5.5X12X0.4MM ST 5 EA; 3M OSCILLATOR SAW BLADE REPLACEMENT, ME-92 COATED 19.5 X 80 X 9MM, 5 EA; 3M OSCILLATOR SAW BLADE REPLACEMENT 19.5 X 86X 1.27MM, 5 EA; MAXI DRVR OSC BLD 10X85X1.27,1.27MM 5 EA; 19.5 X 86 X 1.27MM 3M OSCILLATOR SAW BLADE REPLACEMENT, COATED, 5 EA; ST PILOT DRILL SHT 1 X 10MM; ST PILOT DRL DENTAL 1.5 X 15MM; ST PILOT DRILL SHT 1 X 15MM |
| First new listing | 2026-05-21 |
| Latest new listing | 2026-06-04 |
| FDA registration number | 1061124 |
| Registration expires | 2026-12-31 |
| amount percentile | 96th of 2,570 (median 1, 15.0x median) |
| Peer records CSV (33 NC records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
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CSV columns: Establishment · Role · New listings · Devices · Latest listing · official source URL
- Source agency: openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
- Record date: 2026-06-04
- Data refreshed: 2026-10-28
- Refunds on request within 14 days
Top DeviceEstablishmentPulse records (NC first): Lightning X Products, Inc (manufacturer, Charlotte, NC) · Sterigenics US LLC (contract sterilizer, Charlotte, NC) · Structure Medical, LLC. (contract manufacturer, Mooresville, · Emage Medical, LLC (other, Charlotte, NC) · Medical Action Industries, Inc. 306 (manufacturer, Arden, NC · Browse all by state and category →
LIVE PUBLIC DATA Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) · Last refreshed: Wed, 28 Oct 2026 20:51:27 GMT
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Peer benchmark and outreach value: Sterigenics U.S., LLC and 33 North Carolina peers
- North Carolina DeviceEstablishmentPulse records like this one: 33
- Sterigenics U.S., LLC's amount: 96th percentile of 2,570 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every North Carolina peer: $6,600 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
80 / 100 Score
- Contract manufacturer or sterilizer adding work.
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
- U.S. establishment.
What is the DeviceEstablishmentPulse record for Sterigenics U.S., LLC in Charlotte, North Carolina?
Sterigenics U.S., LLC (Charlotte, NC), a contract sterilizer, added 15 FDA device listings between 2026-05-21 and 2026-06-04.
How does Sterigenics U.S., LLC compare to other North Carolina DeviceEstablishmentPulse records?
This is a top-decile record: its amount of 15 is 15.0x the median of 1 across 2,570 records. It is 153 days old; check the official source for later updates before acting. Its Score of 80/100 puts it among the stronger signals in this feed.
Sterigenics U.S., LLC vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| Sterigenics U.S., LLC | Charlotte, NC | 15 | 96th | 2026-06-04 |
| Isomedix Operations Inc. | S Plainfield, NJ | 16 | 96th | 2026-09-28 |
| Isomedix Operations Inc. | Sandy, UT | 13 | 95th | 2026-10-15 |
| Isomedix Operations, Inc. | Minneapolis, MN | 12 | 95th | 2026-10-14 |
Related records
DeviceEstablishmentPulse: Contract sterilizer DeviceEstablishmentPulse: U.S. establishment DeviceEstablishmentPulse: records in North Carolina
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From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.